EFFECTS OF LOSARTAN ON AORTIC ROOT AND ASCENDING AORTA REMODELING IN PATIENTS WITH BICUSPID AORTIC VALVE. - CARDPED-2010-01

Conditions: PATIENTS WITH BICUSPID AORTIC VALVE.
MedDRA version: 12.1Level: LLTClassification code 10004552Term: Bicuspid aortic valve

Registration Number: EUCTR2010-018880-41-IT

Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Normofunctioning bicuspid aortic valve : dp max inferior to 25 mmHg and aortic regurgitation absent, or trivial, or mild, or mild-moderate; 2. Increased aortic root and/or ascending aorta diameters and/or reduced aortic compliance 3. Age superior or egual to 10 years and inferior to 65 years 4. Written consent form signed
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

dp max superior to 25 mmHg ; aortic regurgitation more than mild-moderate; Normal aortic root and ascending aorta diameters and normal aortic compliance Pregnancy Brest feeding

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effects of losartan on compliance and aortic root and ascending aorta diameters in patients with bicuspid aortic valve.;Secondary Objective: To evaluate the safety of losartan treatment in patients with BICUSPID AORTIC VALVE.;Primary end point(s): Evaluation of aortic root and ascending aorta dilatation and prevalence of reduced aortic compliance in patients with bicuspid aortic valve, Aortic diameters and distensibility and stiffness index in patients without theraphy at baseline and after 1 year, Aortic diameters and distensibility and stiffness index in patients treated with losartan at baseline and after 1 year.

Secondary Outcome Measures